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This is a prospective, observational, exposure-registration and follow-up study of women and their offspring exposed to Keppra® (levetiracetam) and Keppra XR® at the time of conception (i.e., any time from the first day of the last menstrual period) and/or during pregnancy. The UCB AED Pregnancy Registry is designed to monitor pregnancies exposed to Keppra® and Keppra XR® in order to determine if there is a potential increase in the risk of major birth defects compared to rates from women in the general US population.

To estimate the risk of birth defects occurring in live-born offspring of women exposed to Keppra® and Keppra XR® during pregnancy

This study is being conducted in the United States (US). Enrollment in the Registry is voluntary. The UCB AED Pregnancy Registry is sponsored by UCB, Inc. and is managed by INC Research. The scientific conduct and analysis of the Registry is overseen by an Expert Panel consisting of external specialists in teratology/genetics, epidemiology, maternal and fetal medicine, and neurology (external member details available upon request).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:

Child, Adult, Senior

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Sampling Method:

Non-Probability Sample

Study Population

See Inclusion Criteria

- Women who have been diagnosed with Epilepsy and continued their UCB AED medication while pregnant

Criteria

Inclusion Criteria:

The subjects must meet the following criteria for registration:

Enroll prospectively (patient is still pregnant and no structural defects have been noted on a prenatal test)

Exposure to Keppra® and Keppra XR® on or after the first day of the patient's last menstrual period (verified by date or gestational age of exposure)

For patient-initiated enrollments, provide verbal or written consent to participate in the Registry

For patient-initiated enrollments, provide contact information for herself, her HCP, and the infant's HCP (as applicable)